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SN/T 2246-2009: Chemicals. In vitro skin corrosion. Transcutaneous electrical resistance test(TER)
Status: Valid
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| SN/T 2246-2009 | English | 259 |
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Chemicals. In vitro skin corrosion. Transcutaneous electrical resistance test(TER)
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SN/T 2246-2009
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Basic data | Standard ID | SN/T 2246-2009 (SN/T2246-2009) | | Description (Translated English) | Chemicals. In vitro skin corrosion. Transcutaneous electrical resistance test(TER) | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300 | | Word Count Estimation | 10,110 | | Date of Issue | 2009-02-20 | | Date of Implementation | 2009-09-01 | | Quoted Standard | GB/T 21604-2008 | | Adopted Standard | OECD NO.430-2004, IDT | | Regulation (derived from) | National Quality Inspection [2009] No. 67 | | Issuing agency(ies) | General Administration of Customs | | Summary | This standard specifies the chemical resistance test in vitro skin corrosion by principle, test methods and procedures. This standard applies to chemicals in vitro skin corrosion resistance test. | SN/T 2246-2009: Chemicals. In vitro skin corrosion. Transcutaneous electrical resistance test(TER)
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Chemicals.In vitro skin corrosion.Transcutaneous electrical resistance test (TER)
Exit inspection and quarantine industry standard book People's Republic of China
Chemicals in vitro percutaneous skin corrosion resistance test
Posted 2009-02-20
2009-09-01 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
This standard is identical with the Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method No. 430 (April 2004) "in vitro skin
Corrosion resistance test --- percutaneous "(in English).
This standard is the standard text format according to GB/T 1.1-2000 made the following editorial changes.
--- Increasing the scope section;
--- The OECD Chemicals Test Method No. 430 relating to the method of introduction, purpose, scope, etc. instead of the standard introduction.
Appendix A of this standard is an informative annex.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard is drafted by. People's Republic of China Jiangsu Entry-Exit Inspection and Quarantine Bureau.
Involved in the drafting of the standard units. People's Republic of China Shandong Entry-Exit-Entry Inspection and Anhui People's Republic of China
Quarantine Bureau, Changzhou import and export of industrial and consumer product safety testing center.
The main drafters of this standard. Liu Junfeng, Zhang Shao Yan, Wen Jinsong, Jiang Hongxing, Chen Wei, Chen, Wang Xiaofeng.
This standard is the first release of the entry-exit inspection and quarantine industry standards.
Introduction
Skin corrosion refers to the skin after exposure to chemicals produced irreversible skin tissue damage (as defined in the GHS). This standard
Without providing a live animal test and corrosion test methods for chemical analyzes will be conducted.
The corrosivity evaluation usually requires laboratory animals. GB/T 21604-2008 taking into account the experimental animal suffering and pain
Pain, allows the use of in vitro methods for skin corrosion was measured in its appendix, in order to avoid animal suffering and pain.
Completely replace GB/T 21604-2008 main difficulty is formal, independent, in vitro test methods for scientific missing. Former research validation
It can be used as an in vivo study to develop an alternative to the first step of the test, with the progress of this research has been carried out in vitro skin corrosion test
Experimental study on verification methods. These studies led to the creation of the test and the human skin model test.
Studies have shown that rat percutaneous resistance test can be well aware of the difference between the skin and skin corrosive non-corrosive.
This standard can be identified on the corrosive compounds and mixtures thereof. If combined with other existing information (eg pH, structure-activity Off
Department of Human and (or) animal data) by weight of evidence analysis, this standard can also be the identification of non-corrosive compounds and mixtures thereof.
This standard test substance often do not provide information on skin irritation, nor corrosive substances according to GHS classification rules further.
In order to fully assess the local skin reaction after a percutaneous exposure, it is recommended according to GB/T 21604-2008 in the sequential test policy
Related methods provided little or GHS tested.
Chemicals in vitro percutaneous skin corrosion resistance test
1 Scope
This standard specifies the chemical in vitro percutaneous skin corrosion resistance test principle, test methods and procedures.
This standard applies to chemicals in vitro percutaneous skin corrosion resistance test.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 21604-2008 chemicals acute dermal irritation/corrosion test methods
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Skin exposure to chemicals produced in vitro after 4h irreversible skin damage, namely the epidermis and dermis visibility gangrene. Corrosive effect
Characteristic ulcers, bleeding, crusting, skin discoloration due to hot and 14d, the partial alopecia areata and scarring. Histopathological evaluation of the application method
Suspicious lesions.
3.2
Skin electrical resistance, electrical resistance (kΩ) represented. Using Wheatstone bridge detection of ions through the skin, in order to assess the skin's barrier
Function is a simple and stable way.
Principle 4
4.1 The test substance is applied to the two-tier test system placed in the skin surface, keeping 24h. In this test system, between the skin layers
Skin plate can be used as a separate functional layer. Skin plate from euthanized mice age of the rats 28d ~ 30d. If the cuticle or
Barrier function has been destroyed, then the test substance is corrosive. Or damage the stratum corneum barrier function can be obtained by measuring the resistance of the percutaneous
Value (the TER) is below a predetermined threshold level and confirm. Due to large amounts of data show chemical resistance of most percutaneous rat or
High (generally> 10kΩ), or low (generally < 3kΩ), so we chose 5kΩ as the critical value.
4.2 In general, non-corrosive irritant but neither corrosive nor irritant substance or substances do not appear TER below the Pro
Cutoffs. In addition, other skin or other instruments may make the critical value is changed, and therefore the need for further verification.
4.3 staining methods may be added in the test procedure to confirm the positive results (including TER close 5kΩ time). If the cuticle was
Damage, will increase ion permeability, which can be used staining method was validated. Rat skin TER test can be
GB/T 21604-2008 rabbits in corrosion tests to provide evidence. It should be noted in terms of skin corrosion and skin irritation, rabbits
Test than human skin patch test is more conservative.
5 Test methods
5.1 Test Animals
5.1.1 rats as test animals should be selected, because the skin's sensitivity to chemicals in rats in the same test in the past has been
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